Jonasson 2000.

Methods	DESIGN: double‐blind, placebo‐controlled, single‐centre extension trial
Participants	SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 60 INTERVENTION: ICS (budesonide 100 μg/d o.d.): 28 CONTROL: ICS (budesonide 200 μg/d o.d.): 32 WITHDRAWALS: reported AGE: mean (years) (range): INTERVENTION: ICS (budesonide 100 μg/d o.d.): 9.5 CONTROL: ICS (budesonide 200 μg/d o.d.): 10.0 GENDER: male N (%): INTERVENTION: ICS (budesonide 100 μg/d o.d.): 23 (82.1) CONTROL: ICS (budesonide 200 μg/d o.d.): 17 (53.1) ASTHMA SEVERITY: mild asthma ASTHMA DURATION: not reported MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: All participants in the present study were already randomly assigned to 4 parallel groups in balanced blocks 3 months before inclusion in the present study (see study above, Jonasson 1998) ATOPY: N (% of participants): INTERVENTION: ICS (budesonide 100 μg/d o.d.): 20 (71.4) CONTROL: ICS (budesonide 200 μg/d o.d.): 21(65.6) ELIGIBILITY CRITERIA Must have participated in and completed the initial 12‐week trial (see study above, Jonasson 1998) EXCLUSION CRITERIA See study above, Jonasson 1998
Interventions	PROTOCOL DURATION Run‐in = preceded by a 12‐week trial Intervention = 96 weeks DEVICE: Turbuhaler inhalers DOSE OF ICS INTERVENTION: budesonide 100 μg/d CONTROL: budesonide 200 μg/d CRITERIA FOR WITHDRAWAL FROM STUDY:
Outcomes	ANALYSIS: Statistical analysis was carried out on the intention‐to‐treat principle. Missing values for withdrawals were handled by the last value extended principle. Analysis was done by analysis of co‐variance (ANCOVA) and ANOVA models. An additive model was used when diary variables, lung‐function variables and the maximum fall in FEV1 after the exercise test were analysed; a multiplicative model was used when plethysmography variables and PD20 were analysed OUTCOMES GROWTH MEASUREMENT TECHNIQUE: Growth velocity was determined from measurements of participant height at every visit throughout the study period by a wall‐fixed stadiometer (Seca, Hamburg, Germany). Three trained persons carried out all height measurements during the study. The child was measured standing upright without shoes with the heels touching the wall to which the stadiometer was fixed. The movable part of the measuring device was placed lightly on the child's head before the child's height was read from a centimetre scale. At baseline, the participant's height was measured by 2 persons, and the mean value was registered PULMONARY FUNCTION TESTS Change from baseline in maximum fall in FEV1 after exercise test Changes in airway responsiveness (PD20) Difference FEV1, FEF25%, FEF50% and FEF75% at all visits throughout the study period FUNCTIONAL STATUS Asthma symptom scores BIOMARKERS Blood sample for complete blood count and eosinophil count Skin prick tests ADVERSE EVENTS: reported WITHDRAWALS: reported
Notes	PUBLICATION: full paper (2000) FUNDING: not provided CONFIRMATION OF METHODOLOGY: not received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information on sequence generation: “All patients in the present study were already randomised into four parallel groups in balanced blocks 3 months before inclusion in the present study”
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
Selective reporting (reporting bias)	Low risk	Study protocol not available but published reports include all expected outcomes, including those that were prespecified
Other bias	Low risk	Study apparently free of other sources of bias